Methods | Randomized controlled trial Length of follow‐up: 6 days |
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Participants | Number: 206 enrolled children Inclusion criteria: inpatients; well‐nourished infants and children aged 6 to 24 months with watery diarrhoea < 3 days duration, with 3 watery stools per day and at least 1 in the past 24 hours; mild‐to‐severe dehydration Exclusion criteria: bloody diarrhoea, medications, malnutrition, systemic infection Breastfeeding: included |
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Interventions | Intervention group: diosmectite, dose 1 g in infants < 12 months and 1.5 g in older children, every 8 hours, plus zinc (dose not specified) for 5 days Control group: placebo plus zinc |
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Outcomes | Duration of diarrhoea (until first stool of pre‐diarrhoeal consistency) | |
Notes | Location: Pakistan Setting: urban Cause of diarrhoea: not specified Source of funding: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized by lottery |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. Mentions only "lottery method". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Use of placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Per‐protocol analysis. 10 losses to follow‐up (5%), 4 in intervention group, 6 in control group |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol registered. |
Other bias | Low risk | No other biases detected. |